QA Engineer

Abbott; Alameda (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

HIP PPO medical plan

High employer contribution retirement

Tuition reimbursement

Free U education benefit

Job summary

Abbott Diabetes Care in Alameda, CA seeks an Associate Quality Specialist to support Quality Assurance and the Quality System on site, Monday through Friday. You will help implement and maintain the system and ensure compliance.

You’ll participate in CAPA, training, audits, and cross-functional projects, documenting activities promptly and accurately while upholding EHS policies. Collaboration across teams is essential.

Qualifications

• Bachelor’s degree required.
• 0–2 years of internship, co-op or equivalent experience.
• Medical device industry experience and knowledge of FDA QSR and ISO 13485 preferred.

Responsibilities

• Implement and maintain the Quality System.
• Participate in Quality System processes including CAPA.
• Assist in determining quality attributes and provide technical assistance.
• Complete documentation in a timely manner and in accordance with business standards.
• Participate on cross-functional teams.
• Understand and comply with applicable EHS policies.

Skills

Quality assurance

Quality systems

CAPA

Documentation

Cross-functional teamwork

EHS compliance

Education

Bachelor’s degree

Tools

Databases

Computer software

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Associate Quality Specialist

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Associate Quality Specialist is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System.

This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA)

• activities, equipment maintenance, product and process planning, quality audits, validation.

• Assist in determining quality attributes and requirements. may provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Participate on cross-functional teams.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Works under the supervision of more experienced staff who review results for overall accuracy, completeness and sound

• judgment.

• Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and

• makes recommendations and decisions impacting those factors.

• Responsible to meet established objectives and goals.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• May assist in the training of personnel as directed by management.

Required Qualifications

• Bachelor’s degree required.
• 0-2 years of experience in a combination of internship, co-op or equivalent experience.

Preferred Qualifications

• Medical device industry experience preferred.
• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal
• Regulations for Devices.
• Knowledge of ISO 13485 standard.
• Knowledge of quality management techniques and application.
• Ability to clearly, concisely and accurately convey communications.
• Ability to form and develop interpersonal, professional relationships.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Ability to work cross-functionally.
• Demonstrated initiative and problem-solving skills.
• Critical-thinking skills.
• Ability or aptitude to use various types of databases and other computer software.
• Strong organizational skills.
• Ability to prioritize.
• Ability to multitask.
• Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
• Ability to quickly gain knowledge, understanding or skills and is willing to learn

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non‑opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission: Why We Exist

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

EP

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.